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510(k) Data Aggregation
K Number
K211056Device Name
Oxus Sieve Beds
Manufacturer
Oxus, Inc.
Date Cleared
2023-05-31
(782 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
Oxus, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator.
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
Device Description
The subject device is a compatible replacement part of the Inogen One G3 portable oxygen concentrator. ("POC"). Standard portable oxygen concentrators generate oxygen from room air by use of a sieve bed that removes nitrogen, other gases and impurities from the room air and generates oxygen for patients requiring supplement oxygen.
These sieve beds must be replaced on a schedule in order to maintain the POC's ability to deliver the require % oxygen. The subject device is refurbished with existing Inogen One G3 components with a new sieve bed. The final product is equivalent to the Inogen one G3 replacement sieve bed cartridge.
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